Core Insights - PDS Biotechnology Corporation is advancing its VERSATILE-002 Phase 2 clinical trial, focusing on the combination of Versamune® HPV and KEYTRUDA® for treating HPV16-positive head and neck squamous cell cancer (HNSCC) [1][3][6] Clinical Trial Updates - As of May 17, 2024, the trial has enrolled 53 patients, with updated survival data expected to be announced in Q3 2024 [2] - The median overall survival (mOS) for patients remains at 30 months, with a 95% confidence interval lower limit of 19.7 months [7][8] - The trial includes a three-arm registrational study for first-line treatment of HPV16-positive recurrent/metastatic HNSCC, featuring both double and triple combination therapies [3][6] Treatment Mechanism and Efficacy - The combination of PDS01ADC and Versamune® HPV is believed to effectively disrupt tumor defenses while generating targeted T-cells to attack tumors [10] - The company asserts that the current standard of care for recurrent/metastatic HNSCC has survival rates below 18 months, highlighting the potential of their investigational therapies [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 303A College Road East, Princeton, NJ 08540 (Address of principal executive offices) (800) 208-334 ...

Financial Performance - Reported net loss for Q1 2024 was approximately $10.6 million, or $0.30 per share, compared to a net loss of $9.7 million, or $0.32 per share in Q1 2023[5] - General and administrative expenses decreased to approximately $3.4 million in Q1 2024 from $3.6 million in Q1 2023[7] - Total operating expenses rose to approximately $10.1 million in Q1 2024 from $9.4 million in Q1 2023[9] - Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million, up from $56.6 million at the end of 2023[10][20] Research and Development - Research and development expenses increased to approximately $6.7 million in Q1 2024 from $5.8 million in Q1 2023, primarily due to a $1.2 million increase in clinical studies[6] Clinical Trial Results - Updated results from the VERSATILE-002 trial showed a median overall survival of 30 months for patients treated with Versamune® HPV + KEYTRUDA®, compared to published results of 7-18 months for immune checkpoint inhibitors[3] - The best overall response rate (BOR) was 34% for CPS ≥1 and 48% for CPS ≥20, significantly higher than published results for immune checkpoint inhibitors[3] - Progression-free survival was reported at 6.3 months for CPS ≥1 and 14.1 months for CPS ≥20, compared to 2-3 months for immune checkpoint inhibitors[3] Regulatory and Patent Developments - The company announced a two-part registrational trial for a triple combination treatment in HPV16-positive recurrent or metastatic head and neck cancer[8] - The company received patents extending protections for the Versamune® platform through December 2038 and November 2036, respectively[8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to ________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) Delaware 26-4231384 (State or other juri ...

PDS Biotechnology Corporation (NASDAQ:PDSB) Q4 2023 Earnings Conference Call March 27, 2024 8:00 AM ET Company Participants Dr. Frank Bedu-Addo - Chief Executive Officer Lars Boesgaard - Chief Financial Officer Dr. Kirk Shepard - Chief Medical Officer Tom Johnson - LifeSci Advisors Conference Call Participants Carvey Leung - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities James Molloy - Alliance Global Partners Operator Good morning. And welcome to PDS Biotech's call to discuss the company's Year-En ...

Exhibit 99.1 PDS Biotech Announces Clinical Strategy Update and Reports Full Year 2023 Financial Results Unique mechanism of action of the combination of PDS01ADC and Versamune® results in 3-year survival of 75% and 75% overall response rate in advanced head and neck cancer trial As a result, Company to focus late-stage clinical strategy on triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer Strong safety profile of IL-12 fused antibody drug conjugate (PDS ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or ...

PDS Biotechnology Corporation (NASDAQ:PDSB) Q3 2023 Earnings Call Transcript November 14, 2023 8:00 AM ET Company Participants Nicole Jones - Investor Relations Frank Bedu-Addo - Chief Executive Officer Matthew Hill - Chief Financial Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Joe Pantginis - HC Wainwright Laura Suriel - Alliance Resource Partners Operator Greetings and welcome to the PDS Biotechnology Third Quarter 2023 Earnings Call and Webcast ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or othe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or oth ...